Solvay will also be required to conduct a 10-year observational study to evaluate the incidence of fibrosing colonopathy
in cystic fibrosis patients treated with Creon, and to evaluate the risk of transmission of selected porcine viruses in treated patients, according to the FDA approval letter.
This case suggests that multiple etiologic factors, and not simply exposure to pancreatic enzymes, may result in fibrosing colonopathy in adults with cystic fibrosis.
A less well-known complication is fibrosing colonopathy (FCP), characterized histologically by submucosal fibrosis, and clinically by obstructive symptoms.
Cystic fibrosis-associated colitis and fibrosing colonopathy.
High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis.
Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy.
Comparative and experimental pathology of fibrosing colonopathy.
Fibrosing colonopathy in an adult owing to over use of pancreatic enzyme supplements.
The incidence of fibrosing colonopathy, associated with high doses of pancreatic enzymes and/or the use of high strength preparations in the early 1990s (7-9), caused many centres treating CF to review the practices of their patients and collaborate to produce national guidelines (4,10,11).
Individuals with CF and their parents were advised against self-adjusting the dose in the 1990s when fibrosing colonopathy was identified by other centres.